Our Healthbox - Evaluating Interactive Dispensing Systems for Low-Barrier Access to HIV Testing and Harm Reduction.

NCT ID: NCT05516069

Last Updated: 2024-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

5000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-23

Study Completion Date

2026-06-30

Brief Summary

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When REACH Nexus at MAP Centre for Urban Solutions out of St. Michael's Hospital launched its signature program, I'm Ready in 2021, our goal was to democratize access to free HIV self-testing to reach the undiagnosed in Canada. The program, the first of its kind in Canada has been successfully rolling out 50,000 free, HIV self-tests and connecting participants via a mobile app on an iOS or Android smart phone to care.

While this is an important milestone in improving access, REACH knows that more needs to be done. An estimated 20-30% of undiagnosed individuals do not have access to a phone to order the HIV self-tests, and many face multiple barriers to accessing healthcare and harm reduction support: chaotic life circumstances, addiction challenges, stigma and more.

Everyone in Canada should have equitable access to the health care they need. But REACH knows that this is not the case.So, REACH is working hard to change this. hese ongoing barriers inspired us to continue creating innovative solutions, and launch our second signature program, Our Healthbox. Our Healthbox meets people where they are, with what they need for their health and well-being. This program is scaling up innovations in health technologies to reach undiagnosed individuals with HIV. These smart interactive vending machines will be strategically located across Canada. The goal is to reach people where they live to provide free and low barrier access to HIV self-testing kits, STBBI testing and other harm reduction supplies.

Participation in Our Healthbox, as with I'm Ready, also gives us the opportunity to collect important data that will continue to inform and guide REACH Nexus' work to grow and scale innovative health solutions across the country.

Detailed Description

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Our Healthbox is a national research program led by REACH Nexus part of MAP Centre for Urban Health Studies at St. Michael's Hospital, Unity Health Toronto that is rolling out "smart" vending machines across Canada. Our Healthbox provides low barrier access, connecting individuals with complex health and social needs to harm reduction materials, HIV Self-Tests and sexual health supplies.

The goal of the Our Healthbox program is to investigate whether strategically placed "smart" interactive vending machines improve access to HIV self-testing, in addition to harm reduction materials, for people who have systemic and structural barriers to accessing testing, treatment, care and prevention.

REACH Nexus is planning to launch 25-30 vending machines nationally in the first year with a goal of 100 vending machines deployed over the next 3 years. REACH is working with local community-based organizations to host and maintain the program for a minimum of 3 years.

REACH Nexus wants to reach everyone in Canada, including key populations, regardless of who they are or where they live - and to help to support them in their connection to care. There is a focus on reaching people with complex health and social needs and people who have systemic and structural barriers to accessing testing, harm reduction materials, treatment, care and prevention. Key populations include gay and bisexual men who have sex with men, African, Caribbean and Black populations, people who use substances as well as Indigenous, First Nations and Metis people.

Participants will self-recruit to the selected Our Healthbox vending machine locations. At Our Healthbox, services such as product dispensing, education information and location services information will be available to the user. Persons can view supplies and individual products to determine which items (i.e. HIV self-tests, harm reduction supplies, sexual health and wellness supplies) without registration. A location services directory is available for users to identify any nearby community based agency services near Our Healthbox.

As this is a research program, in order to dispense products (except for Naloxone for emergency use) from the machine, users will be asked to consent to the program, create a user profile and answer a few demographic questions. All information collected is anonymous, private and confidential. All products are available to the participant free of charge. For every return visit, users will sign in and answer additional survey questions prior to dispensing product. All information collected remains anonymous.

Investigators will use the RE-AIM Implementation Science Framework to outline our research objectives, questions and intended outcomes. We will evaluate if our program can:

1. reach people who are undiagnosed with HIV who have complex health, social and substance use to know their status and link to the care they need;
2. reach a significant proportion of first-time testers for HIV and subsequently link them to prevention care; and
3. provide access to harm reduction supplies to reduce harms for people who have systemic and structural barriers to accessing testing, prevention, care and treatment.

Conditions

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HIV HIV Self-testing Harm Reduction Sexually Transmitted Diseases Blood-Borne Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Implementation science research: Cross-sectional, prospective, field trial.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

All participants

Group Type EXPERIMENTAL

Our Healthbox (smart vending machine or interactive dispensing system)

Intervention Type OTHER

Our Healthboxes or interactive dispensing systems (IDS) will be placed in various locations across Canada and will house HIV self-test kits (provided by REACH), harm reduction supplies (provided by the provincial governments / local community based organizations; e.g. sterile drug use kits for safer injection, naloxone kits, syringes), other community determined needs (including but not limited to hats, mittens and/or socks, rapid Covid-19 antigen kits, KN95 masks). Individuals will be able to access the HIV self-test kits and harm reduction and other materials directly from the machine. Our Healthbox will also provide health information, and a support services directory for people to find the health care they need - in their community.

Interventions

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Our Healthbox (smart vending machine or interactive dispensing system)

Our Healthboxes or interactive dispensing systems (IDS) will be placed in various locations across Canada and will house HIV self-test kits (provided by REACH), harm reduction supplies (provided by the provincial governments / local community based organizations; e.g. sterile drug use kits for safer injection, naloxone kits, syringes), other community determined needs (including but not limited to hats, mittens and/or socks, rapid Covid-19 antigen kits, KN95 masks). Individuals will be able to access the HIV self-test kits and harm reduction and other materials directly from the machine. Our Healthbox will also provide health information, and a support services directory for people to find the health care they need - in their community.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 16 years or older (except for Quebec: age 18 years or older)
* Person living in Canada (Canadian resident)
* Able to provide consent in English or French (via the machine screen)
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Public Health Agency of Canada (PHAC)

OTHER_GOV

Sponsor Role collaborator

Canadian Foundation for AIDS Research (CANFAR)

OTHER

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sean B Rourke, PhD

Role: PRINCIPAL_INVESTIGATOR

MAP Centre for Urban Health Solutions, St. Micheal's Hospital

Locations

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Ensemble

Moncton, New Brunswick, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Sean B Rourke, PhD

Role: CONTACT

(416) 878-2779

Darshanand Maraj, MBBS

Role: CONTACT

(416) 864-6060 ext. 6493

Facility Contacts

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Debbie Warren

Role: primary

Related Links

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Other Identifiers

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22-062

Identifier Type: -

Identifier Source: org_study_id

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